Extension Study of Asenapine {P06107 (NCT01244815)} for Pediatric Bipolar Disorder (P05898 AM3)



Status:Completed
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:June 2011
End Date:August 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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A 50-Week Open-Label, Flexible-Dose Trial of Asenapine Extension Treatment to P06107 in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P05898)


This study will investigate the safety and tolerability of a flexible dosing regimen of
asenapine for the long-term treatment of manic or mixed episodes associated with bipolar
disorder I in children and adolescents who completed study P06107 (NCT01244815).


Inclusion Criteria:

- Completed study P06107 and demonstrated acceptable degree of compliance with
medication, visits and other study requirements

- Must be male or a female who is not of childbearing potential or who is not pregnant,
not lactating, and is using a medically accepted method of contraception

- Must have a caregiver or responsible person living with the participant who agrees to
provide support to ensure compliance with treatment, visits, and protocol procedures

Exclusion Criteria:

- Positive pregnancy test or intention to become pregnant during the study

- At imminent risk of self-harm or harm to others

- Under involuntary inpatient commitment

- Known serological evidence of human immunodeficiency virus (HIV) antibody
We found this trial at
62
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Charleston, South Carolina 29405
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Charleston, South Carolina 29425
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Charlottesville, Virginia 22903
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